CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,650 enrolled
Drug / intervention
Fasinumab +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03304379
NCT03304379Phase 3Completed

Phase 3 Randomized, Double-Blind, Multi-Dose, Placebo And NSAID Controlled Study To Evaluate The Efficacy And Safety Of Fasinumab In Patients With Pain Due To Osteoarthritis Of The Knee Or Hip

Regeneron Pharmaceuticals·interventional·Posted Oct 9, 2017·Updated Feb 24, 2023

In Brief

A Phase 3 clinical trial evaluating Fasinumab, Diclofenac, and 2 other interventions for Osteoarthritis, Knee and Osteoarthritis, Hip. Completed, enrolled 1,650 participants across 71 sites.

Detailed Summary

The primary objective of the study is to evaluate the efficacy of fasinumab compared to placebo, when administered for up to 24 weeks in patients with pain due to osteoarthritis (OA) of the knee or hip. The secondary objectives of the study are: * To evaluate the efficacy of fasinumab compared to non-steroidal anti-inflammatory drugs (NSAID)s, when administered for up to 24 weeks in patients with pain due to OA of the knee or hip * To assess the safety and tolerability of fasinumab compared to placebo and compared to NSAIDs, when administered for up to 24 weeks in patients with pain due to OA of the knee or hip

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedOct 9, 2017
Enrollment StartOct 26, 2017
Primary CompletionDec 13, 2019
Study CompletionNov 9, 2020
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 8.7 years ago

Interventions

Fasinumabdrug

Solution for injection in pre-filled syringe

Diclofenacother

NSAID active comparator (capsule)

Celecoxibother

NSAID active comparator (capsule)

Matching placebodrug

Fasinumab-matching placebo (solution for injection in pre-filled syringe); NSAID-matching placebo (capsule)